Ignite Creation Date:
2025-12-24 @ 4:43 PM
Ignite Modification Date:
2026-01-22 @ 1:04 PM
Study NCT ID:
NCT02859766
Status:
COMPLETED
Last Update Posted:
2018-02-08
First Post:
2016-07-12
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety and Pharmacokinetics of Abicipar Pegol Intravitreal Injections in Patients With Neovascular AMD
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008268', 'term': 'Macular Degeneration'}], 'ancestors': [{'id': 'D012162', 'term': 'Retinal Degeneration'}, {'id': 'D012164', 'term': 'Retinal Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000630582', 'term': 'abicipar pegol'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-12-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-02', 'completionDateStruct': {'date': '2017-10-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-02-06', 'studyFirstSubmitDate': '2016-07-12', 'studyFirstSubmitQcDate': '2016-08-04', 'lastUpdatePostDateStruct': {'date': '2018-02-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-08-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-10-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Peak Serum Concentration (CMax) for Free and VEGF-Bound Abicipar', 'timeFrame': 'Treatment Group 1: Baseline to Week 20 and Treatment Group 2: Baseline to Week 12'}, {'measure': 'Serum Concentration Immediately before Next Dose (Ctrough) for Free and VEGF-Bound Abicipar', 'timeFrame': 'Treatment Group 1: Baseline to Week 20 and Treatment Group 2: Baseline to Week 12'}, {'measure': 'Time to Cmax (Tmax) for Free and VEGF-Bound Abicipar', 'timeFrame': 'Treatment Group 1: Baseline to Week 20 and Treatment Group 2: Baseline to Week 12'}, {'measure': 'Terminal Elimination Half-Life (t1/2) for Free and VEGF-Bound Abicipar', 'timeFrame': 'Treatment Group 1: Baseline to Week 20 and Treatment Group 2: Baseline to Week 12'}, {'measure': 'Area Under the Serum Concentration-Time Curve from Zero to the End of the Dosing Interval "tau" (AUC0-tau) for Free and VEGF-Bound Abicipar', 'timeFrame': 'Treatment Group 1: Baseline to Week 20 and Treatment Group 2: Baseline to Week 12'}, {'measure': 'Area Under the Serum Concentration-Time Curve from Zero to Infinity (AUC0-inf) for Free and VEGF-Bound Abicipar', 'timeFrame': 'Treatment Group 1: Baseline to Week 20 and Treatment Group 2: Baseline to Week 12'}], 'secondaryOutcomes': [{'measure': 'Serum Levels of Anti-abicipar Antibodies', 'timeFrame': 'Treatment Group 1: Baseline to Week 20 and Treatment Group 2: Baseline to Week 12'}, {'measure': 'Percentage of Participants with Treatment Emergent Adverse Events', 'timeFrame': 'Treatment Group 1: Baseline to Week 20 and Treatment Group 2: Baseline to Week 12'}, {'measure': 'Best Corrected Visual Acuity using an Eye Chart', 'timeFrame': 'Treatment Group 1: Baseline to Week 20 and Treatment Group 2: Baseline to Week 12'}, {'measure': 'Percentage of Participants with Change from Baseline in Full Ophthalmic Exam Findings [i.e. Slit Lamp Exam, Intraocular Pressure (IOP) Measurements, Funduscopic Exam]', 'timeFrame': 'Treatment Group 1: Baseline, Week 20 and Treatment Group 2: Baseline, Week 12'}, {'measure': 'Changes from Baseline in General Physical Condition as Measured through General Physical Exam', 'timeFrame': 'Treatment Group 1: Baseline, Week 20 and Treatment Group 2: Baseline, Week 12'}, {'measure': 'Percentage of Participants with Changes from Baseline in Vital Signs (Blood Pressure, Pulse Rate)', 'timeFrame': 'Treatment Group 1: Baseline, Week 20 and Treatment Group 2: Baseline, Week 12'}, {'measure': 'Percentage of Participants with Change from Baseline in Clinically Relevant Laboratory Values (Serum Chemistry, Hematology, Urinalysis)', 'timeFrame': 'Treatment Group 1: Baseline, Week 20 and Treatment Group 2: Baseline, Week 12'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Macular Degeneration']}, 'descriptionModule': {'briefSummary': 'This study will evaluate the safety and characterize the systemic pharmacokinetics (PK) of free and vascular endothelial growth factor (VEGF)-bound abicipar following single and multiple intravitreal injections of abicipar pegol in treatment-naïve patients with neovascular age-related macular degeneration (AMD).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n-Presence of active subfoveal and/or juxtafoveal choroidal neovascularization (CNV) secondary to age-related macular degeneration (AMD).\n\nExclusion Criteria:\n\n* History of or active periocular, ocular, or intraocular infection.\n* Previous use of verteporfin photodynamic therapy (PDT) or any ocular anti-angiogenic therapy (eg, aflibercept, bevacizumab, ranibizumab, pegaptanib), approved or investigational, for the treatment of neovascular AMD or previous therapeutic radiation in the region.\n* Prior use of ocular anti-VEGF agents for neovascular eye diseases other than AMD.\n* Macular hemorrhage that involves the center of fovea in the study eye.\n* Any prior or current systemic or ocular treatment (including surgery) for neovascular AMD in the study eye.\n* Treatment with ocular corticosteroid injections or implants within 6 months in the study eye.\n* History or evidence of eye surgery: Pars plana vitrectomy, Submacular surgery or other surgical interventions for AMD, Incisional glaucoma surgery or Cataract or refractive surgery within the last 3 months.\n* AMD in the non-study eye that requires anti-VEGF treatment.'}, 'identificationModule': {'nctId': 'NCT02859766', 'briefTitle': 'Safety and Pharmacokinetics of Abicipar Pegol Intravitreal Injections in Patients With Neovascular AMD', 'organization': {'class': 'INDUSTRY', 'fullName': 'Allergan'}, 'officialTitle': 'Evaluation of Safety and Systemic Pharmacokinetics After Single and Repeat Doses of Abicipar Pegol (AGN-150998) Intravitreal Injections in Patients With Neovascular Age-Related Macular Degeneration', 'orgStudyIdInfo': {'id': '150998-012'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Abicipar Pegol_Repeat Dose', 'description': 'Treatment Group 1: Abicipar pegol 2 mg administered to the study eye by intravitreal injection, 3 injections 4 weeks apart. \\[Day 1, Weeks 4 and 8\\]', 'interventionNames': ['Drug: Abicipar pegol']}, {'type': 'EXPERIMENTAL', 'label': 'Abicipar Pegol_Single Dose', 'description': 'Treatment Group 2: Abicipar pegol 2 mg administered to the study eye by intravitreal injection on Day 1.', 'interventionNames': ['Drug: Abicipar pegol']}], 'interventions': [{'name': 'Abicipar pegol', 'type': 'DRUG', 'otherNames': ['AGN-150998'], 'description': 'Abicipar pegol 2 mg administered to the study eye by intravitreal injection.', 'armGroupLabels': ['Abicipar Pegol_Repeat Dose', 'Abicipar Pegol_Single Dose']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85296', 'city': 'Gilbert', 'state': 'Arizona', 'country': 'United States', 'facility': 'Retinal Consultants of Arizona', 'geoPoint': {'lat': 33.35283, 'lon': -111.78903}}, {'zip': '91006', 'city': 'Arcadia', 'state': 'California', 'country': 'United States', 'facility': 'Win Retina', 'geoPoint': {'lat': 34.13973, 'lon': -118.03534}}, {'zip': '90211', 'city': 'Beverly Hills', 'state': 'California', 'country': 'United States', 'facility': 'Retina Vitreous Associates Medical Group', 'geoPoint': {'lat': 34.07362, 'lon': -118.40036}}, {'zip': '92647', 'city': 'Huntington Beach', 'state': 'California', 'country': 'United States', 'facility': 'Atlantis Retina Institute (Atlantis Eyecare)', 'geoPoint': {'lat': 33.6603, 'lon': -117.99923}}, {'zip': '92093', 'city': 'La Jolla', 'state': 'California', 'country': 'United States', 'facility': 'Jacobs Retina Center, Shiley Eye Institute, UCSD', 'geoPoint': {'lat': 32.84727, 'lon': -117.2742}}, {'zip': '91107', 'city': 'Pasadena', 'state': 'California', 'country': 'United States', 'facility': 'California Eye Specialists Medical Group, Inc-Private Clinic', 'geoPoint': {'lat': 34.14778, 'lon': -118.14452}}, {'zip': '33146', 'city': 'Coral Gables', 'state': 'Florida', 'country': 'United States', 'facility': 'University of Miami', 'geoPoint': {'lat': 25.72149, 'lon': -80.26838}}, {'zip': '33770', 'city': 'Largo', 'state': 'Florida', 'country': 'United States', 'facility': 'The Eye Institute of West Florida', 'geoPoint': {'lat': 27.90979, 'lon': -82.78842}}, {'zip': '32503', 'city': 'Pensacola', 'state': 'Florida', 'country': 'United States', 'facility': 'Retina Specialty Institute', 'geoPoint': {'lat': 30.42131, 'lon': -87.21691}}, {'zip': '34994', 'city': 'Stuart', 'state': 'Florida', 'country': 'United States', 'facility': 'East Florida Eye Insititute', 'geoPoint': {'lat': 27.19755, 'lon': -80.25283}}, {'zip': '33880', 'city': 'Winter Haven', 'state': 'Florida', 'country': 'United States', 'facility': 'Center for Retina and Macular Disease', 'geoPoint': {'lat': 28.02224, 'lon': -81.73286}}, {'zip': '46290', 'city': 'Indianapolis', 'state': 'Indiana', 'country': 'United States', 'facility': 'Raj K. Maturi, MD', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}, {'zip': '02114', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Massachusetts Eye & Ear', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '03801', 'city': 'Portsmouth', 'state': 'New Hampshire', 'country': 'United States', 'facility': 'Eyesight Ophthalmic Services, PA', 'geoPoint': {'lat': 43.07704, 'lon': -70.75766}}, {'zip': '28387', 'city': 'Southern Pines', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Caroline Eye Associates', 'geoPoint': {'lat': 35.17405, 'lon': -79.39225}}, {'zip': '44122', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'Cole Eye Institute, Cleveland Clinic', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'zip': '84107', 'city': 'Salt Lake City', 'state': 'Utah', 'country': 'United States', 'facility': 'Rocky Mountain Retina Consultants', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}, {'zip': '53715', 'city': 'Madison', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'Davis Duehr Dean', 'geoPoint': {'lat': 43.07305, 'lon': -89.40123}}], 'overallOfficials': [{'name': 'Cathy Sutherland', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Allergan'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Allergan', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}